Tag Archives: GMP

Health Canada Publish Draft Guidnace on GMP for Medical Gases

Posted on October 21, 2011 by admin| Leave a comment

Health Canada Publish Draft Guidance on GMP for Medical Gases

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The draft guidelines outlined in Good Manufacturing Practices for Medical Gases (GUI-0031), state the generally applicable principles and practices that are acceptable to the Inspectorate and that should facilitate compliance of fabricators, packagers/labellers, distributors, importers, and home care providers of medical gases with Division 2, Part C of the Food and Drug Regulations on Good Manufacturing Practices (GMP).

This guidance document was revised to reflect the current regulatory environment and to clarify certain aspects that have relevance to the companies dealing with medical gases. Due to their unique production and handling characteristics, the application of the GMP Regulations to medical gases may be different from their application to other pharmaceuticals, thus the interpretations provided in the main GMP Guidelines are replaced by those given in this document for medical gases.

The GMP guidelines are available on Health Canada’s Compliance and Enforcement website.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

Posted on January 27, 2011 by admin| Leave a comment

MHRA Publish Guidance for Manufactures on Clinical Investigations in the UK

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These Notes outline the legal requirements relating to the conduct and performance of a clinical investigation as set out in these Regulations. They also provide background and guidance to manufacturers on how to apply for pre-clinical assessment of a proposed clinical investigation in human subjects, involving a device falling within the scope of the Regulations.

Manufacturers wishing to make an application for pre-clinical assessment of a proposed clinical investigation of an active implantable medical device or a medical device to be carried out in part or in whole in the UK should apply to the Medicines & Healthcare products Regulatory Agency of the Department of Health (referred to in this document as the UK  Competent Authority), in accordance with these Guidance Notes.

This guidance is intended as a general explanation of the legislation and should not be regarded as an authoritative statement of the law nor as having any legal consequence. It follows that manufacturers and others should not rely solely on this guidance but should consult the legislation referred to and make their own decisions on matters affecting them in
conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Concept Paper on GMP Quality Control

Posted on January 8, 2011 by admin| Leave a comment

EMA Publish Concept Paper on GMP Quality Control.

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Chapter 6 of the EU GMP guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice including specific aspects for documentation, sampling and testing. General aspects for premises and equipment, documentation and the use of contract laboratories are linked to Chapters 3, 4 and 7, respectively, of the EU GMP guide.

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EMA Publishes Concept Paper on Revision of EU QC GMP Guide

Posted on December 9, 2010 by admin| Leave a comment

EMA Publishes Concept Paper on Revision of EU QC GMP Guide

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Chapter 6 of the EU GMP guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice including specific aspects for documentation, sampling and testing. General aspects for premises and equipment, documentation and the use of contract laboratories are linked to Chapters 3, 4 and 7, respectively, of the EU GMP guide.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA and FDA Seek Candidate for Joint GMP Inspection Programme

Posted on September 2, 2010 by admin| Leave a comment

EMA and FDA Seek Candidate for Joint GMP Inspection Programme.

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The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the US FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.

The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.

Companies can also participate in the pilot exercise by hosting a single join re-inspection (routine surveillance) where both the EMA and the US FDA have separately planned routine surveillance inspections (re-inspections) to take place within a similar time period at a manufacturing site of a medicinal product authorised in the USA and centrally authorised in the European Union.

Companies that wish to participate should contact either gmp@ema.europa.eu and/or CDERInternationalGMP@fda.hhs.gov.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA, The European Drug Regulatory, Publish Q&A’s for Good Manufacturing Practice (GMP)

Posted on August 17, 2010 by admin| Leave a comment

EMA, The European Drug Regulatory, Publish Q&A’s for Good Manufacturing Practice (GMP).

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While the European Medicines Agency welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.

From time to time the European Medicines Agency publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP)

Posted on December 30, 2009 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP).

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This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP)

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Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

Posted on December 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

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This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following:
1. How new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation (ICH) guidance for industry Q3C Impurities: Residual Solvents (Q3C). This guidance contains recommendations on solvent classification and permitted daily exposure.3
2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapter <467> “Residual Solvents” and the Federal Food, Drug, and Cosmetic Act (the Act).
3. How holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with General Chapter <467> and 21 CFR 314.70.
For recommendations on solvent classification and permitted daily exposure, please refer to the ICH Q3C.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA

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Drug Regulators, FDA, Publish Questions and Answers on GMP, and Production, Process, Control

Posted on December 26, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Questions and Answers on GMP, and Production, Process, Control

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Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Production and Process Controls, takes the formatt of a new webpage.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publish Questions and Answers on GMP, and Production, Process, Control

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Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2)

Posted on December 25, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2).

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The Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9 Quality Risk Management) to the development of a product and its manufacturing process. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle4 of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2)

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Drug Regulators EMEA Publish Concept Paper on the Need to Revise the Guidlines on the use of Transgenic Animals in Biological Manufacture.

Posted on August 18, 2009 by admin| Leave a comment

Drug Regulators, Manufacturing, EMEA publish concept paper on using transgenic animals for biological manufacturing.

Following rapid changes in the area and products making it to the market (related article) The EMEA has published the following “CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)”

Introduction to Regulations

Recombinant proteins for medicinal use are routinely produced in bacterial or mammalian cell lines. The regulatory requirements to make and test the production lines and cell banks, and the subsequent manufacture and testing of the medicinal product are well established. Many relevant Guidelines are available for production in cell lines. An alternative production platform for recombinant proteins is transgenic animals, where a foreign gene, which codes for a therapeutically useful protein, is inserted into the genome of the chosen
species and is expressed under the close control of a promoter. The recombinant protein is generally expressed in some easily harvested body component such as milk or eggs and does not harm the animal.

The Problem to Tackle

A guideline was prepared by CPMP and entered into force in July 1995 (3AB7A). Although it contains advice which was useful for a technology platform which was in its infancy, since it came into force, this production method has progressed significantly and the guidance has not been revised to take account of these advances. The current guideline was prepared at a time when the scientific possibilities for transgenic animals were being investigated and no product had been generated for commercial or clinical trial purposes. In addition, many relevant guidelines, such as the ICH Q5 series had not been prepared.

Discussion on the Problem

It is proposed that the scope of the guidance covers the quality issues regarding biological active substances produced by the expression of one or more transgenes stably located in the genome of animals. Production using cloned animals falls outside the scope.

The following improvements to the published guideline have been identified:

  • The current document contains too many references to the benefits of transgenic technology but is not sufficiently detailed technically. A complete re-write to bring the structure of the document in line with the current format of CHMP guidance documents is needed.
  • The lay-out of the document is not logical or easy to follow. It is not broken down into logical sections which follow CTD headings and concepts.
  • There is no specific section on pathogen safety.
  • There is no discussion of specific Quality systems, particularly for generation of transgenic lines, breeding and maintenance of production animals.
  • A discussion on product characterisation is omitted.
  • Breeding strategy is not mentioned, nor the concept of master and working cell/transgenic banks.
  • Control of active substance or raw material is not adequately covered.
  • Advice on residual Host Cell Proteins and DNA is incomplete.
  • Since products from transgenic animals are (to date) the product of sexual reproduction, and not of cloned animals, the potential inherent variability of transgenic proteins needs to be explicitly discussed and the regulatory requirements to map this variability should be updated.
  • Advice on the information which is required regarding development genetics is confusing and should be clarified.
  • Advice is given that material from different genetic lines should not be mixed when producing product for a single license. This advice needs to be reviewed in light of more recent regulatory considerations.

The Biologics Working Party recommends developing a guideline on the use of transgenic animals in the manufacture of biological medicinal products for human use to replace the existing guideline.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators EMEA Publish Concept Paper on the Need to Revise the Guidlines on the use of Transgenic Animals in Biological Manufacture.

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GMP for phase 1, or not GMP as the case may be.

Posted on April 7, 2009 by admin| Leave a comment

The FDA has set a trend towards the reduction of Good Manufacturing Practice (GMP) regulation in phase 1 clinical trials with the publication of guidelines “CGMP for Phase 1 investigational drugs”, this was published in July 2008, but we through it worth mentioning again for reasons that will become clear shortly. Not being a GMP specialist my interpretation is based on a read through the guidelines and comment for other experts in the field. In summary the guidance is that you can manufacture to GMP but without all the documentation that accompanies GMP, its not a return to investigators making drugs in an academic laboratory and giving them to patients, but it does significantly reduce the burden and more importantly the cost of preparing drugs for Phsae1 clinical trials.

Drug regulators are a pragmatic bunch and this is just another example of that good sense being applied, but why bring it up again, well as you all know the European Clinical Trials Directive (ECTD) has brought GMP to European phase 1 clinical trials, however word is starting to spread that Belgium and Holland and some other ECTD countries are interpreting GMP requirements for phase 1 clinical trials in a slightly different way, more along the lines of the US guidelines, and this author wonders if we might see a more “official” relaxing of the stance in Europe.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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